Accelerated Approval Of Lilly’s Alzheimer’s Drug Could Last About 15 Months, CEO Says

 
• By Brenda Sandburg
  
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Lilly expects results from donanemab ongoing confirmatory trial in 2023, while Biogen has nine years to finish its postmarket study. CEO David Ricks discusses impact of aducanumab approval backlash, pricing and national coverage decision at STAT summit.

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Lilly expects to complete confirmatory trial to support accelerated approval of its Alzheimer's disease drug in 2023 • Source: Alamy

Eli Lilly and Company does not expect the fallout from the US Food and Drug Administration’s accelerated approval of Aduhelm (aducanumab-avwa) will prevent its Alzheimer’s disease drug donanemab from getting the same clearance. And anyway, the accelerated approval term may only be about 15 months, compared to the nine years Biogen has to complete its confirmatory postmarket study of Aduhelm.

Lilly chairman and CEO David Ricks discussed the Alzheimer’s disease drug landscape at Stat’s 13 July science breakthrough summit. Asked...

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